Protocol Number: 07-CC-0011

Title:

Hypnosis as a Pain and Symptom Management Strategy in Patients with Sickle Cell Disease

Number:

07-CC-0011

Summary:

This study will examine whether hypnosis can reduce the frequency and intensity of pain in patients with sickle cell disease.

Patients 18 years of age and older with sickle cell disease and a history of pain associated with their disease may be eligible for this study.

Participants are interviewed to assess their frequency and intensity of pain, sleep quality, coping strategies, mood and anxiety and are then randomly assigned to study Group A or B (see below). All participants are given pain diaries to complete at home and turn in at each clinic visit. They undergo the following procedures:

Group A

Weeks 1-4: Receive weekly 60-minute hypnosis sessions, in which they are given suggestions for relieving pain, reducing anxiety, improving sleep and enhancing their health and well-being. The sessions are audio- and videotaped.

Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.

Week 6: Receive a DVD player and DVD with instruction on how to perform self-hypnosis. They practice hypnosis at home as often as needed, but at least once a day. They record in a pain diary in the morning and the evening their amount of pain, medication use, school or work attendance, quality and amount of sleep and number of times they use self-hypnosis.

Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.

Week 12: Are assessed for how they respond to the hypnosis.

Group B

Weeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.

Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.

Week 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains educational materials about sickle cell disease.

Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.

Weeks 13-24: Follow the procedures described in weeks 1-12 for Group A.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

ELIGIBILITY:

Subjects with known or suspected sickle cell disease are eligible to participate in this study.

INCLUSION CRITERIA:

Greater than or equal to 18 years of age.

Diagnosis of Hemoglobin SS sickle cell disease.

Patient identifies history of pain as a significant problem during at least 2 days in the month prior to enrollment.

Written informed consent/assent has been obtained.

EXCLUSION CRITERIA:

Less than 18 years of age.

Unwilling to experience hypnosis or to have hetero-hypnosis sessions recorded.

Non-fluency in written and spoken English.

Physical or other disabilities that prevent adequate participation in hypnotic susceptibility testing.

Does not wish to be video and audiotaped.

Psychosis or psychotic depression.

History of seizures or epilepsy.

Special Instructions:

Currently Not Provided

Keywords:

Hypnosis

Symptom Management

Pain Management

Sickle Cell Disease

Recruitment Keyword(s):

Sickle Cell Disease

Pain

Hypnosis

Condition(s):

Sickle Cell Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Behavioral: Hypnosis

:

Supporting Site:

NIH Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Anbar RD. Self-hypnosis for the treatment of functional abdominal pain in childhood. Clin Pediatr (Phila). 2001 Aug;40(8):447-51.

Anbar RD. Hypnosis in pediatrics: applications at a pediatric pulmonary center. BMC Pediatr. 2002 Dec 3;2:11. Epub 2002 Dec 3.

Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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